QUINOLCEN
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
16-03-2012
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Active ingredient:
enrofloxacin 100 mg/ml
Available from:
Global Vet Health SL
ATC code:
QJ01MA90
Pharmaceutical form:
Oral solution
Therapeutic group:
enrofloxacin
Therapeutic area:
Chicken Broilers, Rabbit Food
Authorization date:
2011-06-22
Summary of Product characteristics
PART IB 1. SUMMARY OF PRODUCT CHARACTERISTICS
B.1. SUMMARY OF PRODUCT CHARACTERISTICS
1. NAM E OF THE VETERINARY M EDICINAL PRODUCT
ES :Aquaflox 100 mg/ml solution for use in drinking water, chicken and rabbits
PT, RO, PL, IT, DE, FR, IK, BE: Quinoflox 100 mg/ml solution for use in drinking water,
chicken and rabbits
2. QUALITATIVE AND QUANTITATIVE COM POSITION
Each ml of the product contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENTS:
Benzyl alcohol …………...14.6 mg
For a full list of excipients, see section 6.1
3. PHARM ACEUTICAL FORM
Solution for use in drinking water.
Clear yellow solution.
4. CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Chickens (Broilers, replacement chickens, broiler breeders) and rabbits
4.2.
INDICATIONS FOR USE
Chickens (Broilers, replacement chickens, broiler breeders)
: Treatment of infections caused by _E. coli_, _Salmonella_ spp and _Mycoplasma_ spp.
Rabbits: Treatment of respiratory infections caused by _P. multocida _sensible to
enrofloxacin.
Where clinical experience, supported where possible by sensitivity testing of the
causal organism, indicates enrofloxacin as the drug of choice.
4.3.
CONTRAINDICATIONS
Do not use in case of renal and hepatic failure.
Do not treat animals with cartilaginous growth disturbance.
Do not use in case of resistance to quinolones.
Do not administer in animals with known hypersensitivity to Enrofloxacin or any other
quinolone.
or to any of the excipients
Do not use in birds producing eggs for human consumption.
Do not use for prophylaxis.
Do not use in cases of confirmed, or suspected, resistance to quinolone
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